ISPE Hands-On Aseptic Processing & Annex 1 and ATMP Manufacturing Training
4-Day Training Event at the European Aseptic and Sterile Environment
20 - 23 FEB 2024 | (EASE) Facility Strasbourg, France
Driven by the expanding biopharmaceutical market but also relevant to small molecule drug product and API manufacturing, aseptic processing is undergoing a technology evolution driven by the new EC GMP Guide Annex 1. Manufacturers which deliver drugs to Europe, must comply with this new regulatory requirement, which impacts all stakeholders. Additionally, suppliers must consider Annex 1 when supplying and installing new equipment or building new production facilities.
To meet the challenges of the new Annex 1 guidance while enhancing industry efforts to develop, manufacture, and reliably deliver quality medicines to patients, ISPE is conducting a 4-day interactive training event in a unique setting, the European Aseptic and Sterile Environment (EASE) Facility in Strasbourg, France. This training provides hands-on opportunities to interact with equipment in a facility built for training pharmaceutical industry workers. During the training sessions, attendees will have the opportunity to conduct aseptic processing steps as well as ATMP manufacturing exercises in the clean rooms at the EASE facility including preparation and aseptic manipulation inside biological safety cabinets.
What to Expect?
Overview of EASE Facility
Strasbourg, France
Training
Aseptic Processing & Annex 1 Overview - Days 1 and 2
Days 1 and 2 of the hands-on training event will focus on aseptic processing & Annex 1. Under the constraints of a Grade B clean room, attendees will work closely with fill and finish aseptic lines where instructors explain the various options for setting up the equipment and loading stoppers.
Finally, a follow-up virtual meeting will be conducted to allow additional Q&A with the instructors.
Note: To maximize the time in the clean room area, several modules of training material will be sent prior to the event for pre-read and Q&A time will be allotted during the instructional sessions.
Upon completing days 1 and 2 of this event, you will be able to:
- Understand the new EC GMP Guide Annex 1 and its impact on future aseptic processing
- Determine the current industry standards for manufacturing and environmental control
- Engage in critical topics discussion in regulators inspections
- Introduction to the regulatory framework
- Quality risk management
- Interaction of process and aseptic fill/finish operations
- Principles of aseptic processing
- Facilities design
- Process development and validation
- Interactive session/case-based learning/inspections with pre-read material discussions
- How to prepare for regulatory inspections (pre-read)
- Pre-Course work materials
- Interactive exercises
- Hands on exercises in clean rooms will cover topics including:
- Gowning
- Use of single use bags, connection with different systems
- The ROTA filling machine
- RABS
- Smoke diffusion to understand the impact on equipment with gloves
- Machine set up
- Learning assessments
- EC GMP Guide Annex 1, 2023
- FDA CFR 210 and 211
Jean Francois Duliere is a Pharmacist by education. Jean Francois started his professional life 20 years in pharmaceutical industry Quality Control, Production in various positions and various fields, OSD, Steriles, API from Bacteria growth. Jean Francois joined after this production experience an Engineering company Technip where he stayed for 20 years doing facilities design for OSD; Sterile, Biotech, Vaccines, Advanced Therapy Medicines facilities. In charge of early design stages and GMP compliance of most of Technip's pharma projects. Jean Francois is involved in many ISPE working groups and committees.
ATMP Manufacturing Overview - Days 3 and 4
Days 3 and 4 of the hands-on training event will be focused on Advanced Therapy Medicinal Products (ATMPs) manufacturing. Course material is focused on the commercial manufacture of ATMP drug products in manufacturing facilities. Training will focus the proper implementation of facilities and equipment to ensure that quality products are consistently manufactured, as well as addressing potential manufacturing issues. Material will be drawn from the ISPE ATMPs Autologous Cell Therapy Good Practice Guide (GPG). Course material establishes guiding principles from the GPG that should be considered in the implementation of ATMP manufacturing processes. The training will be presented from the perspective of an allogeneic or autologous cellular therapy or gene-modified cellular therapy. Attendees in this course will have the opportunity to participate in hands-on exercises inside a clean room where they will learn how to conduct aseptic operations under a biological safety cabinet (BSC). Additionally, participants will be provided an overview of upstream and downstream processes.
- Defining ATMPs
- Regulatory considerations
- Manufacturing definition
- Unit operations
- Manufacturing controls
- Segregation
- Facility considerations
- Supply chain management
- Technology transfer
- Scale-up/scale-out
To maximize the time in the clean room area, several modules of training material will be sent prior to the event for pre-read and Q&A time will be allotted during the instructional sessions.
- Introduction to ATMPs
- The science behind ATMPs
- Regulatory aspects/QRM of ATMP manufacturing with focus on cell therapies
- Supply chain considerations for ATMPS with focus on cell therapies
- Manufacturing considerations for ATMPs with focus on autologous cell therapies
- Facility Considerations and minimum requirements
- Tech transfer, scale-up, and supply chain considerations
- Pre-Course work materials
- Interactive hands-on exercises will cover topic including:
- Gowning to access clean areas
- Exercises on BSC manipulation, aseptic product transfer, and the use of connectors and bags
- Touring the downstream process area
- Tips on answering regulators finding involving clean rooms
- Guide: ATMPs - Autologous Cell Therapy
- Background and impact of personalized medicine
- Defining the baseline platforms of ATMPs and how they differ from current biomanufacturing operations
- Cell therapies
- Gene therapies
- Understanding of regulatory requirements
- Understanding of the fundamentals of manufacturing process definitions
- Process descriptions
- Process attributes
- Supply chain characteristics
- Equipment considerations
Jean Francois Duliere is a Pharmacist by education. Jean Francois started his professional life 20 years in pharmaceutical industry Quality Control, Production in various positions and various fields, OSD, Steriles, API from Bacteria growth. Jean Francois joined after this production experience an Engineering company Technip where he stayed for 20 years doing facilities design for OSD; Sterile, Biotech, Vaccines, Advanced Therapy Medicines facilities. In charge of early design stages and GMP compliance of most of Technip's pharma projects. Jean Francois is involved in many ISPE working groups and committees.
Who should attend this 4-Day hands-on training event?
- Production operators, quality assurance and quality control specialists, validation scientists, manufacturing supervisors, technical support personnel, engineers, and all levels of management having assigned ATMP-focused roles/responsibilities
- Managers of production and quality assurance
- Process engineers
- Engineers responsible for infrastructure and maintenance
- Quality managers
- Shop floor supervisors
- Suppliers for equipment and infrastructure of aseptic manufacturing plants
- A/E consultants in facility design
- Project/manufacturing engineering resources engaged in ATMP project execution
- Personnel who need an in-depth understanding of the potential risks around ATMP manufacturing
- Service organizations, suppliers, and vendors who serve pharmaceutical industry clients focused on ATMP manufacturing
- Academic Institutions engaged in ATMP development/manufacturing
- Vendors and suppliers of equipment/systems focused on the global ATMP “launch”
- Scale
- Closed systems & single-use
- Patient-specific therapies
Pricing
| Early Registration | Regular Registration | |
|---|---|---|
| Member | $4,700.00 | $5,000.00 |
| Non Member | $5,000.00 | $5,600.00 |
| Government | $1,600.00 | $1,600.00 |
| Student | $1,000.00 | $1,000.00 |
Gallery
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Production & QC area upstream
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Production & QC area upstream 2
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Production area for sterile liquids
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Production area for dry forms
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Air treatment system
Location
EASE, Campus d’ILLKIRCH 80 route du Rhin 67400 ILLKIRCH, France EU